Clinical Trials

In a lecture titled “The history, goals and meaning of experimental Research,” students explore the evolution of experimental research in healthcare and medicine, from early observations to modern clinical trial standards. The role of experimental research in evaluating the effectiveness and safety of new treatments, medicines, medical technologies and care interventions is being looked at.

In lectures on the design, methodology and phases of clinical trials, students acquaint themselves with the basic principles of clinical trial planning, the main study designs and their application in healthcare research. Clinical trial phases, their objectives, participant engagement principles, data acquisition and evaluation approaches and methodological aspects that ensure the scientific quality, reliability and safety of the study are considered.

In the lecture “ethical aspects in Biomedical and Clinical trials,” students acquaint themselves with the key principles of research ethics to be followed when planning and implementing research with human involvement. The protection of subjects’ rights, safety, dignity, privacy and goodwill and the importance of informed consent in clinical trials are addressed.

In the lecture “monitoring of clinical trials and data Management”, students acquaint themselves with the principles of quality assurance, monitoring and documentation of clinical trials. The role of study monitoring in the protection of participant safety, compliance with protocol requirements, assurance of data reliability and compliance of study progress with the requirements of good clinical practice shall be considered.

In the “basics of Pharmacovigilance” class, students acquaint themselves with the importance of pharmacovigilance in clinical trials and healthcare, with a particular focus on monitoring the safety of medicines, recognising, documenting and reporting adverse reactions. Basic concepts of pharmacovigilance such as adverse event, serious adverse event, adverse drug event and unexpected adverse event are considered.

In the practice, students analyze examples and situations where patient safety needs to be evaluated, different types of adverse events should be distinguished, and reporting needs determined. The lesson develops the ability to apply pharmacovigilance principles to clinical trial documentation and understand the responsibility of the research team to ensure the safety of participants.

In the “risk Management in Clinical trials” class, students acquaint themselves with the importance of risk management in planning and implementing clinical trials, paying particular attention to ensuring participant safety, data quality and study compliance. The principles of good clinical practice, the responsibility of the research team, identification, evaluation, mitigation and monitoring of risks throughout the duration of the study are considered.

In the practice, students analyze potential risks in the clinical trial protocol, such as participants’ safety risks, data gaps, protocol deviations, documentation errors, and failure to comply with ethical requirements. The lesson develops the ability to apply the principles of good clinical practice and develop risk mitigation measures to ensure the quality of the study, the protection of participants’ rights and the reliability of the data obtained.

In the “Clinical trials of Medical devices” class, students become acquainted with the specificities of clinical trials of medical devices, the principles of planning, implementation, documentation and supervision thereof. Differences between clinical trials of medicinal products and medical devices, classification of medical devices, evaluation of safety and performance, as well as regulatory and ethical requirements for conducting such studies are considered.

In the practice, students analyze examples of medical device studies, evaluate potential risks to the patient, study design specificities, data collection requirements, and principles for reporting adverse events. The lesson develops the ability to understand the specificities of medical device studies and apply the principles of clinical trial methodology, good clinical practice and patient safety in the evaluation of medical devices.

In the lesson “audits and inspections in clinical trials”, students acquaint themselves with the importance of audits and inspections in ensuring the quality, safety and compliance of clinical trials. It is considered how audits and inspections help assess the conformity of the research process with the protocol, good clinical practice requirements, regulatory enactments and quality standards of the research documentation.

In the practice, students analyze more common discrepancies in clinical trials, such as incomplete documentation, protocol deviations, insufficient informed consent process, data discrepancies, and safety reporting delays. The lesson develops the ability to prepare for an audit or inspection, identify potential quality risks and understand the responsibility of the research team in implementing corrective and preventive actions.

In the lesson “Health outcomes indicators in Clinical trials”, students become acquainted with the importance of health outcomes indicators in the planning, implementation and interpretation of clinical trials. Primary and secondary outcome indicators, clinical, patient reported and functional outcomes are considered, as well as the role of their choice in achieving the objective of the study and ensuring the reliability of the results.

In the practice, students analyze examples of clinical trials, identify the outcome indicators used in them, and evaluate whether they are consistent with the purpose of the study, the design of the study, and the group of participants. The lesson develops the ability to formulate, justify and critically evaluate the health outcomes indicators to be used in the clinical trial protocol.

In the lesson “Management of investigational medicinal products and data”, students acquaint themselves with the basic principles for the circulation of investigational medicinal products and the management of clinical trial data. Consideration is given to receiving, storing, dispensing, accounting, returning or destroying investigational medicinal products, as well as documentation requirements that ensure the traceability of the medicinal products and the safety of participants.

During the practice, students analyze situations related to the accounting of investigational medicinal products, temperature control requirements, dose issuance, documentation of non-compliances and compliance with protocol requirements. At the same time, we are looking at the principles of data management: data collection, input, verification, correction, storage, confidentiality and traceability. The lesson develops the ability to ensure correct management of investigational medicinal products and data in accordance with the requirements of good clinical practice.

In the lesson “study population, selection principles, sample size determination”, students acquaint themselves with the basic principles of the definition of the study population, selection of participants and sample selection in clinical trials. The concepts of target population, available population and study sample are considered, as well as the role of inclusion and exclusion criteria in ensuring the quality, safety and generalizability of the study results.

In the practice, students analyze examples of clinical trials, evaluate participants’ selection criteria, and discuss sample representativeness, selection errors, and possible prejudices. The basic principles for determining sample size are also considered, including the importance of the study objective, outcome indicators, statistical capacity and expected withdrawal of participants. The lesson develops the ability to correctly define the study population, develop selection criteria, and argue for sample selection in the clinical trial protocol.

In the lesson “Clinical study Protocol” students present the clinical trial protocols developed during the course and justify the chosen topic, topicality, purpose, tasks, study design, population, selection criteria, outcome indicators, data acquisition and analysis plan, as well as ethical and safety aspects of the study.

During the lesson, students demonstrate the ability to present their research intention in a structured and reasoned manner, link theoretical knowledge to practical protocol development and answer questions about methodological, ethical and organisational solutions. The lesson serves as a final examination of the course, in which the student’s ability to independently develop, justify and defend the clinical trial protocol is assessed.